Analytical method validation for metformin quantification in dissolution medium

Authors

  • Joselyn Bogantes-Molina Pharmacy School, Universidad Latina of Costa Rica, San José, Costa Rica.
  • German Leonardo Madrigal-Redondo Pharmacy School, Universidad Latina of Costa Rica, San José, Costa Rica.
  • Lorena Berrocal-Barrantes Pharmacy School, Universidad Latina of Costa Rica, San José, Costa Rica.
  • Marianela Chavarría-Rojas Pharmacy School, Universidad Latina of Costa Rica, San José, Costa Rica.
  • Daniel Alejandro Acuña-Amador Faculty of Pharmacy, University of Costa Rica, San José, Costa Rica.
  • Rolando Vargas-Zúñiga Faculty of Pharmacy, University of Costa Rica, San José, Costa Rica.

DOI:

https://doi.org/10.30574/gscbps.2019.7.2.0049

Keywords:

Biological and Pharmaceutical Sciences, Validation, Analytical method, Quantification, Dissolution, Spectrophotometry

Abstract

Metformin hydrochloride is a hypoglycemic agent used for type II Diabetes Mellitus treatment, and one of the most used to manage it. The objective of the present work was the development and validation of an analytical method to quantify metformin hydrochloride in the dissolution medium by UV spectrophotometry. Linearity and range, accuracy and precision were the validation process parameters. Validation process results showed the analytical method was easy, quick, secure and, furthermore, a linear, accurate and precise method in the studied concentrations range.  Therefore, it is a reliable analytical method.

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References

Gong L, Goswami S, Giacomini K, Altman R and Klein T. (2012). Metformin pathways: pharmacokinetics and pharmacodynamics. Pharmacogenetics and Genomics, 2-13.

United States Pharmacopoeia 40 (USP). (2017). United States Pharmacopoeia 40 (40 ed.). Rockville: U.S. Pharmacopoeial Convention.

Wegscheider, W. (1996). Validation of Analytical Methods. In: H. Günzler, Accreditation and Quality Assurance in Analytical Chemistry, Berlin, 134-158

COMIECO. (2006). Reglamento Técnico Centroamericano: Productos Farmacéuticos. Validación de Métodos Analíticos para la Evaluación de la Calidad de los Medicamentos. From http://asp.salud.gob.sv/regulacion/pdf/rtca/rtca_11_03_3906_productos_farmaceuticos_metodos_analiticos.pdf

Ministerio de Salud de Costa Rica. (s.f.). Guía de Validación de Métodos Analíticos. San José. From http://www.netsalud.sa.cr/ms/drc/pciudadano/guia_01.doc

Food and Drugs Administration (FDA). (1996). Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology. Rockville. From https://www.fda.gov/downloads/drugs/guidances/ucm073384.pdf

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Published

2019-05-30

How to Cite

Bogantes-Molina, . J., Madrigal-Redondo, G. L., Berrocal-Barrantes, L., Chavarría-Rojas, M., Acuña-Amador, D. A., & Vargas-Zúñiga, R. (2019). Analytical method validation for metformin quantification in dissolution medium. GSC Biological and Pharmaceutical Sciences, 7(2), 043–051. https://doi.org/10.30574/gscbps.2019.7.2.0049

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